LOVASTATINA 20 mg Coated Tablet

Зміст інструкції

1. LOVASTATINA MYLAN PHARMA 20 mg tablets, 40 mg tablets
   1. What LOVASTATINA MYLAN PHARMA is and what it is used for
   2. What you need to know before taking LOVASTATINA MYLAN PHARMA
   3. How to take LOVASTATINA MYLAN PHARMA
   4. Possible side effects
   5. How to store LOVASTATINA MYLAN PHARMA
   6. Contents of the pack and other information

LOVASTATINA MYLAN PHARMA 20 mg tablets, 40 mg tablets

Lovastatina

Generic medicine

Read this leaflet carefully before you start taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What LOVASTATINA MYLAN PHARMA is and what it is used for
• 2. What you need to know before you take LOVASTATINA MYLAN PHARMA
• 3. How to take LOVASTATINA MYLAN PHARMA
• 4. Possible side effects
• 5. How to store LOVASTATINA MYLAN PHARMA
• 6. Contents of the pack and other information

1. What LOVASTATINA MYLAN PHARMA is and what it is used for

Lovastatina Mylan Pharma contains the active ingredient lovastatin, which belongs to a
group of medicines that reduce blood lipid levels, such as cholesterol and
triglycerides.
Lovastatina Mylan Pharma is used for:

• Reducing high cholesterol levels in the blood (primary hypercholesterolemia, including familial hypercholesterolemia) or high lipid levels in the blood (mixed hyperlipidemia) when diet, physical activity, and weight loss have not yielded satisfactory results.
• Reducing high cholesterol levels in the blood when you have a high risk of serious cardiovascular disease and diet has not yielded satisfactory results.
• Reducing high cholesterol levels in the blood and decreasing the risk of a heart attack when you have heart blood vessel disease (ischemic heart disease) and diet has not yielded satisfactory results.

2. What you need to know before taking LOVASTATINA MYLAN PHARMA

Do not take Lovastatina Mylan Pharma

• if you are allergic to lovastatinor to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other statins
• if you have problems with your liveror elevated liver enzymes in your blood
• if you have problems with the bile duct(cholestasis),
• if you have muscle weakness or tenderness(myopathy)
• if you are taking any of the following medicines to treat infections: itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone
• if you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Lovastatina Mylan Pharma:

• if you have severe breathing difficulties (interstitial lung disease which manifests with shortness of breath, unproductive cough, fatigue, weight loss and fever). In this case, consult your doctor who will stop the treatment.
• if you have had liver problems in the past.Your doctor will prescribe blood tests to check your liver before starting treatment with Lovastatina Mylan Pharma, 6 and 12 weeks after starting therapy, whenever your dose is increased and at least 2 times a year regardless of dose changes.
• if you regularly drink large amounts of alcohol
• if you are taking or have taken in the last 7 days a medicine called fusidic acid. The combination of fusidic acid with Lovastatina Mylan Pharma can lead to serious muscle problems (rhabdomyolysis)
• if you have suffered a serious injury or need to undergo surgery
• if you suffer from a rare inherited high cholesterol condition (familial hypercholesterolemia homozygote)
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

During treatment with this medicine, your doctor will carefully monitor that
you do not have diabetesor are at risk of developing diabetes. You are at risk of
developing diabetes if you have high levels of sugars and fats in your blood, if you are
overweight and have high blood pressure.
Lovastatina Mylan Pharma can cause muscle problems(myopathy) that
manifest with muscle pain, soreness, tenderness, weakness related to the
prescribed dose. Sometimes these problems can be serious (destruction of muscle
cells) and cause kidney problems; rarely they can lead to death.
The risk of muscle problems is significantly increased when Lovastatina Mylan
Pharma is taken with other medicines (see Other medicines and Lovastatina Mylan
Pharma).
The risk of muscle problemsmay also be due to the simultaneous presence
of:

• imbalances of mineral salts in the body
• convulsions
• thyroid disease
• lowering of body temperature (hypothermia)
• increased acidity in the blood (metabolic acidosis)
• reduced oxygen in the body (hypoxia)
• viral infections
• drugs and substances of abuse (cannabinoids, alcohol, amphetamine, cocaine, LSD, ecstasy, etc.) The doctor in the cases described above will decide whether you should stop treatment with Lovastatina Mylan Pharma or continue taking it by defining the daily dosage.

If you have started therapy with lovastatin or your dose has been increased, you are at a higher
risk of muscle problems (myopathy). Tell your doctor about any spontaneous or induced muscle pain
(e.g. from palpation), fatigue, weakness, fever, dark urine and elevated levels of creatine kinase (an enzyme produced especially in the
muscles). The doctor may decide to stop treatment and have blood tests performed.
Also, tell your doctor or pharmacist if you have persistent muscle weakness.
Further tests and medications may be needed for diagnosis and treatment
of this condition.
You are more likely to develop muscle problems if you have severe kidney disease
resulting from long-term diabetes.
Before dental extractions, tell your dentist that you are being treated with Lovastatina
Mylan Pharma. Inform your doctor a few days before undergoing surgery
or other invasive medical procedure. Always inform your doctor and healthcare professionals
that you are taking Lovastatina Mylan Pharma.

Children and adolescents
The use of Lovastatina Mylan Pharma is not recommended in children and
adolescents under 18 years of age, because the safety and
efficacy have not been established in children.

Other medicines and Lovastatina Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines:
The risk of muscle problems is significantly increased if you are taking
simultaneously with Lovastatina Mylan Pharma or other medicines of the same
type:

• a medicine to regulate your heart rhythm based on amiodarone
• a medicine to lower blood pressure based on verapamil

The risk of muscle problems may also be increased in cases where you are
taking Lovastatina Mylan Pharma with:

• drugs for infections (antibiotics), such as erythromycin, clarithromycin, norfloxacin, telithromycin, troleandomycin
• drugs against fungal diseases, such as fluconazole, itraconazole, ketoconazole, metronidazole, miconazole
• fusidic acid: if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily interrupt treatment with this medicine. Your doctor will tell you when it is safe to resume taking Lovastatina Mylan Pharma. Taking Lovastatina Mylan Pharma with fusidic acid can, rarely, lead to weakness, tenderness or muscle pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.
• drugs for HIV/AIDS such as HIV protease inhibitors, delavirdine, indinavir, nelfinavir, ritonavir, saquinavir
• niacin (nicotinic acid), gemfibrozil, or other fibrates that lower cholesterol. These medicines in combination with lovastatin can increase the risk of developing muscle problems.
• immunosuppressants that reduce resistance to disease, for example cyclosporine
• quinine against malaria
• cimetidine, omeprazole (for excess stomach acid)
• danazol, to treat endometriosis
• diltiazem, mibefradil, beta-blockers, some diuretics that lower potassium in the blood (for heart and high blood pressure)
• fluoxetine, fluvoxamine, St. John's wort, nefazodone, sertraline, barbiturates (for depression and anxiety)
• propoxyphene (for inflammation)
• zafirlukast, theophylline, terbutaline (for asthma)
• colchicine (for gout)
• anticoagulants to prevent blood clots, for example warfarin

Lovastatina Mylan Pharma with food, drinks and alcohol
Do not take Lovastatina Mylan Pharma on an empty stomach.
Grapefruit juice contains one or more ingredients that can compromise
the effectiveness of medicines. Avoid taking large amounts of grapefruit juice,
alcohol or chamomile products.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.
The use of lovastatin is contraindicated during pregnancy and breastfeeding.
If you are a woman of childbearing potential, your doctor will ask you to perform a pregnancy test
before starting treatment with Lovastatina Mylan Pharma.

Driving and operating machinery
Lovastatin usually does not affect the ability to drive and operate
machinery. However, you may feel dizzy. Avoid driving and operating machinery in
case of feeling unwell after taking lovastatin.

Lovastatina Mylan Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 20
mg and 40 mg tablet and per maximum daily dose of 80 mg, i.e. it is essentially
“sodium-free”.

3. How to take LOVASTATINA MYLAN PHARMA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take Lovastatina Mylan Pharma during dinner.
If your doctor has prescribed the medicine twice a day, take one tablet at
breakfast and one at dinner. Do not take LOVASTATINA MYLAN PHARMA on an empty stomach.
Before starting treatment, you must begin a low-cholesterol diet, to be
continued during treatment with lovastatin.
The fracture line is only to facilitate breaking the tablet in case you
have difficulty swallowing it whole.
High blood cholesterol levels (hypercholesterolemia)
The initial dose in adults is 20 mg per day in the evening during the meal.
The doctor may adjust your daily dose at intervals of four weeks up to
a maximum of 40 mg per day. The doctor will reduce the dose in case of excessive lowering
of cholesterol levels (cholesterol-LDL below 75 mg/100 ml and total cholesterol below 140 mg/100 ml).
High blood cholesterol levels not corrected by diet alone in the presence of
heart blood vessel disease (ischemic heart disease)
The initial dose in adults is 20 mg per day in the evening during the meal. The doctor may
adjust your daily dose at intervals of four weeks up to a maximum
of 80 mg per day in a single dose or by taking two doses, one at breakfast and the other at
dinner. The doctor will reduce the dose in case of excessive lowering of cholesterol levels (cholesterol-LDL below 75 mg/100 ml and total cholesterol below 140 mg/100
ml).
The doctor may deem it necessary to modify the doses, especially if you are taking
some of the medicines listed above (see “Other medicines and Lovastatina Mylan
Pharma”), if you are elderly, if you suffer from kidney problems (severe renal failure) or if
you suffer from diseases that increase the risk of muscle problems (untreated hyperthyroidism, hereditary myopathy or following treatment with other statins or fibrates, alcoholics).
Use in children and adolescents
The use of Lovastatina Mylan Pharma is not recommended in children and adolescents
under 18 years of age, because the safety and efficacy have not been established in
children.

If you take more Lovastatina Mylan Pharma than you should
In case of accidental intake of an excessive dose, immediately notify your
doctor or go to the nearest hospital. Also bring the box and any remaining tablets
with you.

If you forget to take Lovastatina Mylan Pharma
If you forget to take a dose, take it as soon as you remember unless it is
almost time for the next dose. Do not take a double dose to make up for the
missed tablet.
Failure to take a dose does not compromise the effectiveness of therapy. Resume
taking it according to the established therapeutic schemes without recovering the missed dose.

If you stop taking Lovastatina Mylan Pharma
The doctor will inform you how long you need to take the tablets. Do not stop
taking the medicine without first consulting your doctor. If you have any doubts
about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
not all people will experience them.

Common: may affect up to 1 in 10 people
stomach problems
dizziness
headache
impaired vision
intestinal gas (flatulence)
diarrhea
constipation
nausea
indigestion
abdominal pain
skin rash
muscle cramps
muscle pain (myalgia)

Uncommon (may affect up to 1 in 100):
taste disturbances
itching
dry mouth
fatigue
insomnia
sleep disorders

Rare (may affect up to 1 in 1,000):
Allergic syndrome (hypersensitivity) with one or more of the following symptoms:
or anaphylaxis (severe allergic reaction)
or angioedema (swelling of skin, lips or tongue)
or lupus-like disease syndrome (autoimmune disease that can
affect the skin, joints, heart, lungs, kidneys and brain)
or autoimmune diseases (dermatomyositis)
or polymyalgia rheumatica (rheumatic disease with pain in the shoulder and
hips)
or vasculitis (inflammation of blood vessels)
or
or thrombocytopenia (decreased platelets in the blood)
or leukopenia (decreased white blood cells in the blood)
or eosinophilia (increased number of a type of white blood cells)
or hemolytic anemia (anemia caused by an abnormal decrease in
red blood cells)
or positive anti-nuclear antibodies (when the body attacks itself)
or increased erythrocyte sedimentation rate (a blood test that measures
inflammation)
or arthritis (inflammation of the joints) and arthralgia (joint pain)
or urticaria
or muscle weakness (asthenia)
or sensitivity to light
or fever
or flushing
or difficulty breathing
or malaise (general feeling of discomfort)
loss of appetite
psychiatric disorders including restlessness or anxiety
nerve damage causing numbness and weakness in the arms and legs
(peripheral neuropathy), especially if taken for a long period of time,
tingling sensation (paresthesia)
vomiting
liver inflammation (hepatitis), yellowing of the skin and eyes (cholestatic
jaundice)
hair loss
severe skin rashes: redness of the skin with blisters and peeling for
Stevens Johnson syndrome or toxic epidermal necrolysis (TEN)
weakness and muscle pain, abnormal muscle breakdown that can lead to
kidney problems due to conditions such as myopathy and rhabdomyolysis
erectile dysfunction
blood tests may show increased levels of liver enzymes
(transaminases), changes in liver function tests (alkaline phosphatase,
gamma-glutamyltransferase, bilirubin) or an increase in creatine kinase
(an enzyme that indicates muscle damage).

Frequency not known:
depression
immune-mediated necrotizing myopathy
myasthenia gravis (a disease that causes generalized muscle weakness
including, in some cases, the muscles used for breathing).
ocular myasthenia (a disease that causes weakness of the eye muscles).
See your doctor if you experience weakness in your arms or legs that worsens after
periods of activity, double vision or drooping eyelids, difficulty swallowing or
shortness of breath.

Other side effects:
lupus erythematosus
red spots on the body (purpura)
thyroid function abnormalities
diabetes mellitus
lung problems (interstitial lung disease)
enlargement of the breasts in men (gynecomastia), sexual problems,
loss of libido
sleep disorders and nightmares
memory loss, abnormal functioning of some nerves (cranial nerve dysfunction), tremor, dizziness
progressive loss of transparency of the eye (cataract), paralysis of the eye muscles (ophthalmoplegia)
inflammation of the pancreas (pancreatitis), reduced appetite
malignant liver tumor (hepatoma)
accumulation of fat in liver cells (steatosis), severe
liver damage (cirrhosis), rapid and massive death of liver cells (fulminant hepatic necrosis)
joint pain (arthralgia),

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store LOVASTATINA MYLAN PHARMA

Keep this medicine out of the sight and reach of children.
Do not use LOVASTATINA MYLAN PHARMA after the expiry date which is stated
on the box and on the blister after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.
Do not store at a temperature above 30°C.

6. Contents of the pack and other information

What Lovastatina Mylan Pharma contains
The active ingredient is lovastatin
Each tablet contains 20 mg of Lovastatina
Each tablet contains 40 mg of Lovastatina
The other ingredients are:
Microcrystalline cellulose PH102
Microcrystalline cellulose PH101
Mannitol
Sodium croscarmellose
Talc
Magnesium stearate
Anhydrous colloidal silica
Sodium lauryl sulfate

Description of the appearance of Lovastatina Mylan Pharmaand contents of the
pack

• Lovastatina 20 mg: white, biconvex, scored, cylindrical tablet. Diameter
• 6.0±0.3 mm. The break line is only to facilitate breaking for easier swallowing, and not for dividing into equal doses.
• Lovastatina 40 mg: white, biconvex, scored, cylindrical tablet. Diameter
• 8.25±0.3 mm. The break line is only to facilitate breaking for easier swallowing, and not for dividing into equal doses.

Pack size: 30 tablets

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan - Italy

Manufacturer
Laboratorium Sanitatis S.L.
Parque Tecnológico de Álava. c/ Leonardo Da Vinci 11 01510 Miñano (Álava), Spain